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NanoViricides, Inc. is a NYSE-American listed publicly traded company (stock symbol: NNVC). This is not an offering memorandum and should not be construed as such. It is provided as a non-confidential document for informational purposes only.
NanoViricides, Inc.(www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials as therapeutics against a number of different viruses. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. All of our drug candidates are based on broad and exclusive worldwide licenses in perpetuity from TheraCour Pharma, Inc. for the development of drugs to combat viral infections of Human Coronaviruses, Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex Viruses (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu viruses, Dengue viruses, Ebola/Marburg viruses, Japanese Encephalitis virus, viruses causing viral Conjunctivitis (a disease of the eye). The Company’s technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. The Company’s business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
This document contains forward-looking statements that reflect the current expectation of NanoViricides, Inc. (the “Company) regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements are “forward-looking statements” within the meaning of Section 27A of the Securities18 Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements.
The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities.
Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in pre-clinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
SARS-CoV-2 Therapeutics Development Strategy and Status
Lead Drug Candidates Against SARS-CoV-2
Developing Drugs that Virus May Not Escape due to Mutations
Industry-Leading Platform Technology Exclusively Licensed from TheraCour Pharma, Inc.
Our Own cGMP-Capable Manufacturing, R&D, and Nanomedicine Characterization Facility Enables Rapid Development and Potential for Early Commercialization Revenues On Our Own
NV-HHV-101 for Shingles Rash Indication - IND prioritized after SARS-CoV-2
Non-GLP Safety Toxicology Studies of Both NV-CoV-2 and NV-CoV-2-R Completed Strong Safety at Very High Dosage Levels
10
Rats dosed at up to 562 mg/kg body weight by tail vein intravenous injection on Days 0,1,3,5,7,9 for a total of 3,375mg/kg dose of NV-CoV-2 showed no side effects
Rats dosed at up to 309 mg/kg body weight by tail vein intravenous injection on Days 0,1,3,5,7,9 for a total of 1,855mg/kg dose of NV-CoV-2-R showed no side effects
No evidence of any severe adverse reactions was observed during the administration or during the study period and at postmortem examination
NV-CoV-2, NV-CoV-2-R and Vehicle groups tolerated the compounds similarly
The body fluids and fecal analysis showed no significant difference between the groups
Histopathological examination showed no changes either in the areas of small intestine
or large intestine
No changes in organ weight or histology were observed in all dose groups.
Additional Future Indications in HerpeCide Program
Chickenpox (Possibly Orphan Drugs)
PHN (Post-Herpetic Neuralgia)
Recurrent Herpes Labialis
HSV-1 Cold Sores
Dermal Topical Cream
Herpes KeratitisVZV Shingles
HSV-2 Genital Lesions
Genital Lesions Topical Cream
“ARN” Acute Retinal Necrosis
not reveal any publication regarding this difference in ARNpatients. This research was approved by the IRB at theUniversity of Virginia.
Case descriptionA 64-year-old female with a history of mild leukopeniawas referred with a 1 week history of progressivelyincreasing floaters with ‘fogging’ of vision and photo-phobia in the left eye with no changes in the right eye.The patient reported a history of right-sided herpes zosterophthalmicus 1 month prior for which she completed a10 day course of famciclovir. Past medical history includedchicken pox in preschool and genital herpes (diagnosed22 years prior and treated with acyclovir). She denied ahistory of human immunodeficiency virus (HIV) disease.Pinhole visual acuity was 20/25 + 1 right eye (OD)
and 20/60 left eye (OS). There were no vesicular le-sions or preauricular lymphadenopathy on examination.
Slit lamp examination of the OD was unremarkablewhile the OS showed circumcorneal injection, mildanterior uveitis with moderate vitritis and haze. Fundusexamination of the right eye was insignificant. Examin-ation of the left eye was remarkable for vasculitis, alarge area of wedge necrosis inferonasally from 6 to 7o’clock and five small areas of necrosis temporally fromapproximately 3 to 5 o’clock with poorly defined mar-gins (Figure 1).The patient was clinically diagnosed with ARN and
underwent anterior chamber paracentesis for viral poly-merase chain reaction analysis, but there was insufficientfluid for analysis. She was admitted and started on IVacyclovir 600 mg Q8 h for 7 days [3]. Laboratory blood-work revealed elevated VZV IgG, HSV1 IgG and cyto-megalovirus (CMV) IgG levels. On day 3, the patientagreed to 0.1 ml Foscarnet (2.4 mg/0.1 mL) intravitrealinjection OS [10,11]. On day 4, the retinitis appeared
Figure 1 FAF imaging results. (A-C) Color fundus photograph and fluorescein angiography demonstrating presentation of an ARN lesion andvasculitis. (D-F) Color fundus photographs and FAF imaging demonstrating hyperautofluorescent borders adjacent to areas of complete retinalnecrosis characterized by hypoautofluorescence 3 months following presentation. (G-I) Five months after presentation and after photocoagulationtreatment color photos and fundus autofluorescence images demonstrate arrest of the disease margin in high contrast. The lesion margins werestable (unchanged) at 10 months.
Ward and Reddy Journal of Ophthalmic Inflammation and Infection (2015) 5:19 Page 2 of 4
VZV, HSV-1, HSV-2 mainly
Eye Drops
Dermal Topical Cream
Market Size for HerpeCide™ Program Drugs estimated at Over $3-$5 Billion Lead Indication Shingles Rash Market Size estimated at $1 Billion or More
(takes into account impact of Shingrix and other Vaccines)
Our Current Focus is on the HerpeCide™ Program Regulatory Development
NanoViricides Leveraging Herpecide Program Developments into Multiple Drugs Franchise
Independent Board Member and Chair of Audit Committee since June 2012
Hon’ble Theodore “Todd” Rokita, JD ✔ Former US Rep. from Indiana (4 terms since 2010). Served on several House Committees. Co-owner, General Counsel
and Vice President of External Affairs, Apex Benefits Group, Inc. Extensive executive, team-building, business strategy,
and fiscal management expertise in the private sector, alongside his public service leadership experience. Serves
or has served as a Member of the Board of Directors of several commercial and charitable institutions.
Independent Board Member since May, 2020
Mak Jawadekar, PhD ✔ 35+ Years of Pharmaceutical Industry Experience, Pharma Strategic Consultant. Previously at Pfizer, Inc., as Director, Portfolio Management & Analytics, and as Vice President,
Asia Colleague Resource Group, in Pfizer Global R&D. Business and Research experience in joint ventures,
alliance management, contracting, pharma R&D, drug delivery, clinical supply manufacture, etc. Global experience
working with United States, Europe, India, Japan, China.
Independent Board Member since February, 2020
✔ = Independent Board Member
Brian M. Zucker, CPA ✔ 30+ years of experience as a CPA specializing in the
securities industry. A Partner at CFO Financial Partners, LLC (https://www.cfopartners.com/). Also serves as the CFO
and Financial Operations Principal for numerous broker dealers and hedge funds. Partner at RRBB Accountants &
Advisors. CFO of EIG Energy Partners Capital Markets, LLC. Ex-Senior Consultant at Deloitte Haskins & Sells and at
Price Waterhouse. Mr. Zucker holds several FINRA licenses.